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Consultations

Revised: 28 May 2013

Outcome of Consultation on Changes to the Medsafe's Administrative Processes and Fees Effective 1 July 2009

19 June 2009

To: Medicine, related product and clinical trial sponsors and applicants Regulatory affairs staff and consultants

Changes to the Medsafe's administrative processes and fees effective 1 July 2009

The purpose of this letter is to:

1. Changes to Medsafe's administrative processes

On 1 July 2009 Medsafe will introduce new processes (signalled in April 2009) for the collection of fees payable under the Medicines Act 1981.

This change will mean that companies are no longer required to send money with an application or notification.

Following receipt of an application or notification, a tax invoice will be sent to the applicant with an acknowledgement letter. Payment will be requested within 7 days and will be required to validate the application/notification.

Reminders will be sent in relation to unpaid invoices. Applications and notifications will, however, be invalid if payment has not been received by the 20th of the month following the month in which the invoice was issued.

Applicants and sponsors should note that:

2. Updated schedule of fees

In April 2009, Medsafe undertook consultation on proposed changes to fees payable under the Medicines Act 1981. The outcome of that consultation is available on the Medsafe website (www.medsafe.govt.nz).

Some of the proposed changes will be implemented, while others will not proceed at this time. However, it is important to note that in almost all instances, the actual fees or the way in which fees are calculated will change on 1 July 2009. From this date, Changed Medicine Notification fees will reduce by 10% and certain fees relating to New Medicine Applications will no longer apply.

The fees are shown in the revised fee schedule.

The revised fees apply to applications received from 1 July 2009 onwards. The current fee schedule applies to all applications received up to and including 30 June 2009.

If you have any queries about the information provided in this letter, please contact:

Brian Strickland
Business Manager
brian_strickland@moh.govt.nz
DDI: (04) 819 6809

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